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New Health Claim System Could Herald Healthy Profits

Shane Starling | Nov 01, 2003

United States

Companies with unique ingredients or end products could gain government-sanctioned, near-proprietary marketing tools under the liberalised health claims system introduced by the US Food and Drug Administration in September, according to a leading industry analyst.

Speaking at the recent Natural Products Expo East trade show in Washington, DC, Loren Israelson, president of Utah-based LDI Group, highlighted the commercial potential of qualified health claims. Qualified claims are based on ?good, but not entirely conclusive? evidence and, if accepted by the FDA, will receive an A-to-D grading depending on the scientific strength of the petition. The FDA says it will process all claims within 270 days.

Israelson believes dietary supplement and functional foods manufacturers as well as ingredient suppliers have been presented with an opportunity to gain a competitive edge.

?The FDA?s view is that it has to be a generic claim that doesn?t relate to a specific branded product or ingredient,? said Israelsen. ?But I think there is an opportunity if there aren?t too many ingredients or products of that kind on the market to get a generic claim that is quite specific to a particular product or ingredient.

?It could distinguish it from everybody else in the market and until competitors have demonstrated equivalence they can?t use that claim. I venture very few folks understand the ramifications of this while others are going to jump on it and gain that commercial advantage.? One company to have jumped already is Israeli ingredient supplier Lycored Natural Products which, together with Heinz and other unnamed companies, is putting together a submission based on the cancer-fighting properties of Lycored?s natural tomato complex, Lycomato.

Lycopene, the antioxidant found in tomatoes, is well known to have cancer-fighting capabilities, but because Lycored and Heinz will apply for the claim in relation to Lycored?s particular product, Lycomato, synthetic lycopene manufacturers may be precluded from attaching the claim to their products.

There is, however, concern over the new system. Two groups, the Center for Science in the Public Interest (CSPI) and Public Citizen, have taken legal action against the FDA for failing in its duty to protect consumers. ?The FDA is illegally putting consumers? health at risk and allowing food companies to turn the supermarket aisle into a Tower of Babble,? said a CSPI spokesperson. In the middle ground are those who see both boon and bane with the looser requirements. ?More information is good for consumers, but we don?t know how valuable it really will be,? said Kim Smith, director of legislative affairs at the National Nutritional Foods Association. ?The FDA?s qualifying language takes away quickly what they?ve given.?

—Shane Starling

The New System In A Nutshell Legal action begun in 1999 spurred the new system as the Federal Appellate Court deemed FDA?s standard of evidence required for claims under the old system was too high and restricted potentially useful information being made available to consumers. A follow-up case in 2001 confirmed this view.

The new A?D graded interim claims system officially came into being on September 1, 2003, on a trial basis. In this first stage, FDA will review each petition on a case-by-case basis but the agency expects to develop formalised regulations at some point in 2004 based on this system.

A typical qualified claim would read something like: ?Scientific evidence suggests but does not prove that eating 1.5 ounces per day of most nuts, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.?

Within 15 days of receipt, FDA will acknowledge all petitions.

Within 45 days, FDA will post petitions on the FDA Web page for a 60-day public comment period. Petitions that don?t meet content requirements will be rejected and returned to submitters at this point. During the 60-day comment period, written comments may be submitted by the public.

Within 270 days of receiving petitions, FDA will inform the petitioner of its final decision, which will then be posted on FDA?s Web site.

Petitioners are expected to nominate whether they are applying for a qualified or unqualified health claim.